Table 3.
Clinical characteristics of reports with capecitabine from the FAERS database (2004–2023).
| Variables | Overall (N = 45,011) |
|---|---|
| Sex | |
| Female | 26,498 (58.9%) |
| Male | 14,908 (33.1%) |
| Missing | 3605 (8.0%) |
| Weight (kg) | |
| <50 | 928 (2.1%) |
| >100 | 861 (1.9%) |
| 50–100 | 8802 (19.6%) |
| Missing | 34,420 (76.5%) |
| Age (years old) | |
| <18 | 71 (0.2%) |
| 18~64.9 | 15,111 (33.6%) |
| 65–85 | 12,829 (28.5%) |
| >85 | 820 (1.8%) |
| Missing | 16,180 (35.9%) |
| Reporter | |
| Consumer | 12,203 (27.1%) |
| Physician | 10,319 (22.9%) |
| Pharmacist | 6988 (15.5%) |
| Other health professional | 4875 (10.8%) |
| Lawyer | 29 (0.1%) |
| Missing | 9586 (23.5%) |
| Outcome | |
| Other serious (important medical events) | 12,630 (25.3%) |
| Hospitalization—initial or prolonged | 11,228 (22.5%) |
| Death | 6972 (14.0%) |
| Life-threatening | 1217 (2.4%) |
| Disability | 359 (0.7%) |
| Required intervention to prevent permanent impairment/damage | 110 (0.2%) |
| Congenital anomaly | 16 (0.0%) |
| Missing | 17,334 (34.8%) |
| Reporter country | |
| United States of America | 31,141 (69.2%) |
| China | 1743 (3.9%) |
| United Kingdom | 1601 (3.5%) |
| Japan | 1157 (2.6%) |
| Canada | 838 (1.9%) |
| France | 855 (1.9%) |
| Germany | 800 (1.8%) |
| Italy | 772 (1.7%) |
| Spain | 517 (1.1%) |
| Netherlands | 498 (1.1%) |
| Others | 4456 (9.9%) |
FAERS, Food and Drug Administration Adverse Event Reporting System.